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Cancer Vaccine
NeoVax + CDX-301 + Nivolumab for Melanoma
Phase 1
Recruiting
Led By Patrick A Ott, MD, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have histologically confirmed stage IIIB/C/D or stage IV cutaneous melanoma (mucosal melanoma or uveal melanoma are excluded) that is surgically resected, is deemed surgically resectable, or is unresectable; tumor tissue for sequence analysis must be available from either previous melanoma resection/biopsy or at least one site of disease must be amenable to surgical or core biopsy
Creatinine ≤ 1.5 x ULN OR Creatinine clearance ≥40 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
Must not have
Test positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
Pregnant women are excluded from this study because Nivolumab, personalized neoantigen peptides and poly-ICLC are agents with unknown risks to the developing fetus. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with Nivolumab, personalized neoantigen peptides and poly-ICLC, nursing women are excluded from this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up toxicities experienced within 49 days/7 weeks of neoantigen vaccine treatment initiation
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a personalized vaccine called NeoVax, combined with other drugs, to treat melanoma. The vaccine is made from the patient's own tumor proteins to help the immune system fight cancer. The study aims to find a safe way to use these treatments together and determine the right dose.
Who is the study for?
Adults with stage IIIB/C/D or IV melanoma that's resectable or unresected, and not mucosal/uveal type. Must have good performance status, normal organ/marrow function, no severe allergies to study drugs, no HIV/AIDS or hepatitis B/C infection. Women must test negative for pregnancy and agree to contraception; men also need to use contraception.
What is being tested?
The trial is testing a combination of NeoVax (a personalized cancer vaccine), CDX-301, and Nivolumab against melanoma. Participants will receive these drugs to see if they work better together in treating the disease compared to current standard treatments.
What are the potential side effects?
Possible side effects include reactions at the injection site from the vaccine, flu-like symptoms such as fever and chills, fatigue, skin reactions like rash or itching. Nivolumab can cause immune-related issues affecting organs like lungs or intestines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma is confirmed, operable or not, and tissue is available for testing.
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My kidney function is within the required range.
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I am fully active or can carry out light work.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have tested positive for hepatitis B or C.
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I am not pregnant or breastfeeding.
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I am not planning any major surgery, except possibly for melanoma removal.
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I haven't taken any cancer drugs or immunosuppressants in the last 6 months.
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I haven't taken high-dose steroids or immunosuppressants in the last 14 days.
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I am allergic to Nivolumab or CDX-301.
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I have active cancer spread to my brain or its coverings.
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I do not have any ongoing serious illnesses or infections.
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My cancer has Flt-3 mutations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ toxicities experienced within 49 days/7 weeks of neoantigen vaccine treatment initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~toxicities experienced within 49 days/7 weeks of neoantigen vaccine treatment initiation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of Dose Limiting Toxicity (DLT)
Recommended maximum tolerated dose (MTD)
Secondary study objectives
Estimate rates of disease progression/recurrence depending on whether patient had all melanoma resected or has measurable disease per RECIST 1.1
Neoantigen-specific cellular immune responses
Side effects data
From 2024 Phase 3 trial • 529 Patients • NCT0201771780%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: CDX-301 + Neovax + PembrolizumabExperimental Treatment3 Interventions
* Participants will have vaccine made from tissue collected from tumor biopsy, or from previously collected archival biopsy or surgical tissue.
* Participants will receive neoadjuvant Pembrolizumab for 3 doses every 3 weeks, then undergo standard-of-care surgical resection.
* Participants will receive adjuvant NeoVax and CDX-301. CDX-301 will be administered at a predetermined dose, dependent on the number of participants previously enrolled, for 5 days starting 2 days before the initiation of NeoVax. CDX-301 will then be administered at a predetermined dose dependent on the number of participants previously enrolled 2 days before and for 5 days coinciding with the administration of NeoVax on days 50 and 78.
* Participants will receive adjuvant Pembrolizumab for 15 doses every 6 weeks.
Group II: CDX-301 + Neovax + NivolumabExperimental Treatment3 Interventions
* Participants will have vaccine made from tissue collected from metastatic tumor biopsy or surgical resection, or from previously collected archival biopsy or surgical tissue.
* Participants will receive Nivolumab at a flat dose every 4 weeks up to two years.
* Participants will receive CDX-301 at a predetermined dose dependent on the number of participants previously enrolled for 5 days starting 2 days before the initiation of NeoVax. CDX-301 will then be administered at a predetermined dose dependent on the number of participants previously enrolled 2 days before and for 5 days coinciding with the administration of NeoVax on days 50 and 78.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3130
CDX-301
2017
Completed Phase 1
~170
Nivolumab
2015
Completed Phase 3
~4010
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for melanoma, particularly advanced cases, include immunotherapies such as checkpoint inhibitors (e.g., nivolumab, pembrolizumab) and personalized vaccines like NeoVax. Checkpoint inhibitors work by blocking proteins that prevent T-cells from attacking cancer cells, thereby enhancing the immune response against melanoma.
NeoVax, a personalized neoantigen vaccine, stimulates the immune system to recognize and target specific mutations unique to an individual's tumor. This personalized approach can lead to a more effective and targeted immune response, potentially improving outcomes for melanoma patients by reducing tumor growth and spread.
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,113 Previous Clinical Trials
358,851 Total Patients Enrolled
32 Trials studying Melanoma
2,848 Patients Enrolled for Melanoma
Celldex TherapeuticsIndustry Sponsor
65 Previous Clinical Trials
5,907 Total Patients Enrolled
8 Trials studying Melanoma
439 Patients Enrolled for Melanoma
Patrick A Ott, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
11 Total Patients Enrolled
1 Trials studying Melanoma
11 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease but it's either mild or under control.I am not breastfeeding if I decide to participate in this study.You have been diagnosed with HIV or AIDS.I agree to use contraception during and for 7 months after the study.I will use birth control or abstain from sex during and 5 months after the study.I have tested positive for hepatitis B or C.I am not pregnant or breastfeeding.My melanoma is confirmed, operable or not, and tissue is available for testing.Your bilirubin levels must be within a certain range, unless you have Gilbert Syndrome, in which case there is a different range.My kidney function, based on my age, weight, and creatinine levels, is suitable.My kidney function is within the required range.I am fully active or can carry out light work.I haven't had any vaccines (except for COVID-19) 4 weeks before or during my treatment.I have melanoma and haven't had anti-CTLA-4 therapy but stopped PD-1 inhibitors over 6 months ago.I had cancer before but have been cancer-free for 3 years or had certain types of cancer treated.Your white blood cell count is at least 3,000 per microliter.I am not planning any major surgery, except possibly for melanoma removal.I haven't taken any cancer drugs or immunosuppressants in the last 6 months.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I am allergic to Nivolumab or CDX-301.My organ and bone marrow functions are normal.I have active cancer spread to my brain or its coverings.You have had a serious allergic reaction to any vaccine for preventing diseases.I do not have any ongoing serious illnesses or infections.I am 18 years old or older.I have recovered from previous cancer treatment side effects, except for hair loss or skin changes.I am a woman who can have children and have a negative pregnancy test before starting treatment.My cancer has Flt-3 mutations.You have a certain level of white blood cells.Your platelet count is at least 100,000 per microliter.Your liver enzymes (AST and ALT) must not be more than 3 times the upper limit of normal.Your hemoglobin level is higher than 9.0 grams per deciliter.My kidney function, based on my age, weight, and creatinine levels, is adequate.
Research Study Groups:
This trial has the following groups:- Group 1: CDX-301 + Neovax + Nivolumab
- Group 2: CDX-301 + Neovax + Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.